Clearance Summary
STABILET received FDA 510(k) clearance under submission number K942904, sponsored by Hill-Rom, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1994-09-16.
- Submission: K942904
- Applicant / Sponsor: Hill-Rom, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5130
- Decision date: 1994-09-16
Classification & Regulation
This clearance is catalogued under FDA product code FMT and 21 CFR 880.5130, within the General Hospital review panel as a Class II device.